BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3800509 · Received May 8, 2014

    Report

    Report Number
    1416980-2014-14830
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS RECEIVED FOR ANALYSIS. INSPECTION OF THE PHOTOGRAPH FOUND NO CLEAR EVIDENCE OF LEAKAGE INSIDE OF THE OVERPOUCH THAT CONTAINED THE SAMPLE. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSOR ELASTOMERIC DEVICE LEAKED INTO THE OVER-POUCH. THIS EVENT WAS NOTED PRIOR TO USE. NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277293 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13N034

    Patients

    Seq Age Sex Outcome Treatment
    1